The U.S. Food and Drug Administration today announced that a group of medications used to control high blood pressure, called angiotensin receptor blockers (ARBs), do not increase the risk of developing cancer in patients using the medications.
Category Archives: Drug Safety Information Podcasts
FDA: Breast thermography not a substitute for mammography
The U.S. Food and Drug Administration today warned women not to substitute breast thermography for mammography to screen for breast cancer.
FDA seeks injunction concerning uneviscerated seafood and other fish at Minnesota company
The U.S. Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, is seeking a permanent injunction against BCS African Wholesale Food Supply LLC (BCS African Wholesale) of Brooklyn Park, Minn. and its principal officers. If granted, the injunction would force the defendants to stop importing, processing, and selling seafood products that can put consumers at risk for botulism or that may present other food safety hazards.
FDA approves injectable gel to treat fecal incontinence
The U.S. Food and Drug Administration today approved a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.
FDA approves treatment for Clostridium difficile infection
The U.S. Food and Drug Administration today approved Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD).
FDA to make enforcement and compliance activities accessible online
The U.S. Food and Drug Administration today announced that it is disclosing more information about inspections and court actions, and now has a web portal on its enforcement activities as part of Phase II of the agency’s Transparency Initiative. These actions are being taken to make FDA’s enforcement and compliance-related activities more accessible, downloadable, and searchable online.
FDA seeks comment on preventive controls against foodborne illness
The Food and Drug Administration is seeking public comment on preventive control measures for food facilities through a public docket opened this week as part of the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in January.
FDA takes action against illegal marketing of tobacco products
The U.S. Food and Drug Administration today announced it issued 11 warning letters last week to online retailers for illegally marketing tobacco products with misleading or unsubstantiated claims or descriptors indicating that they can be used to reduce harm or the risk of tobacco-related disease.
FDA approves Incivek for hepatitis C
The U.S. Food and Drug Administration today approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin.
FDA: Do not feed SimplyThick to premature infants
The FDA is advising parents, caregivers and health care providers not to feed SimplyThick, a thickening product, to premature infants. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition.